MELBOURNE, Australia, Dec. 17 /PRNewswire-FirstCall/ -- Phosphagenics Limited (“Phosphagenics”) today announced positive results of its Phase 1 clinical trial that showed its delivery technology, TPM, delivered leading pain-relief drug oxycodone through the skin without causing disruption or irritation of any kind.
These results support Phosphagenics’ aims to be the first company to commercialize a sustained release oxycodone patch for the management of chronic pain.
“Oxycodone, with worldwide annual sales of more than $1 billion, is more potent than morphine with fewer adverse effects; however, oxycodone is not available transdermally due to serious issues relating to skin sensitization and irritation,” said Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics. “Our trial results show that TPM can deliver oxycodone through the skin in a sustained release formulation without causing skin irritation.”
This trial, which was conducted by CMAX (an independent clinical research organization located at the Royal Adelaide Hospital) was a single-centre, single-blinded, pharmacokinetic trial in 16 healthy subjects. The trial endpoints were to evaluate the safety and tolerability of the TPM/Oxycodone formulation and the ability of the TPM technology to deliver oxycodone into the body.
The oxycodone, administered as a single transdermal application, was safe with no adverse events reported. Oxycodone was detected in the subjects for at least 48 hours. The results demonstrate that the formulation is bioavailable and effective in delivering oxycodone into the body.
A collaborative program is now under way with a world leading patch development company to incorporate the current formulation into a patch system. Plans are also underway to undertake a pivotal clinical study in the first half of 2008.
“Developing our pain relief pipeline builds on the success of Phosphagenics’ previous transdermal clinical trials and provides a platform for the development of many other products,” added Dr. Ogru.
Mr. Harry Rosen, President and CEO of Phosphagenics, said: “Completing this Phase 1 trial was an important milestone for our pain management program. We are delighted to have successfully completed this trial and look forward to progressing to the next phase.”
About Phosphagenics Limited
Phosphagenics is a Melbourne-based, globally driven biotechnology company focused on the discovery of new and cost effective ways to enhance the bioavailability, activity, safety and delivery of proven pharmaceutical and nutraceutical products.
Phosphagenics’ core technology is built around the science and application of phosphorylation, a process where the addition of a phosphate group has been found to enhance the bioavailability, activity and safety of existing pharmaceuticals and nutraceuticals, as well as to assist in the production of drug delivery platforms.
Phosphagenics’ shares are listed on the Australian Stock Exchange (POH) and the London Stock Exchange’s Alternative Investment Market (PSG). An ADR - Level 1 program was established in the U.S. with The Bank of New York Mellon (PPGNY) for U.S. investors to trade in Phosphagenics’ stock on the ‘over-the- counter’ market. In July 2007, this was upgraded to the International OTCQX, a new premium market tier in the U.S. for international exchange-listed companies, operated by Pink Sheets, LLC.
For more information, please visit Phosphagenics’ web site at http://www.phosphagenics.com.
Safe Harbor Statement
This press release contains forward-looking statements based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from the Phosphagenics’ expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations.
CONTACT: Harry Rosen, President and CEO, +61-3-9605-5900, or Mary Bennett,
Investor Relations Manager, +61-3-9605-5907, both of Phosphagenics Limited;
or U.S. Investors and Media, Brian Ritchie of FD, +1-212-850-5683, for
Phosphagenics Limited
Web site: http://www.phosphagenics.com/
